J&J launches large-scale study of COVID-19 vaccine

COVID vaccine

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Rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca all require two shots separated by several weeks, which make them much more hard to administer.

According to new guidelines revealed on Monday by the Washington Post, the government's key agency overseeing the multiple Covid-19 vaccine trials will soon roll out more comprehensive, long-term tracking requirements to gain approval.

The company said it was poised to imminently publish the results from an earlier stage of the trial on a medical preprint site.

(MENAFN - Baystreet.ca) Johnson & Johnson (NYSE:JNJ) said Wednesday it has begun its phase three trial testing its potential coronavirus vaccine.

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The company's shares rose 2% before the opening bell on Wednesday. The company plans to release those results imminently.

J&J's study, named ENSEMBLE, will recruit 60,000 volunteers across eight countries-Argentina, Brazil, Chile, Columbia, Mexico, Peru, South Africa and the U.S. Given the data showing that some groups are more vulnerable to the effects of COVID-19, Dr. Paul Stoffels, chief scientific officer at J&J, said the company and its study leaders are focusing on ensuring that the study includes a diverse population of participants.

The FDA announced that it would institute more rigorous standards and follow-up protocols before approving an emergency use authorization of any Covid-19 vaccine.

As the Times describes, "many vaccines - including ones for measles, polio, and tetanus - were designed from the outset to be given to children".

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Participants are due to take the second vaccine shot a month after starting the trials, but The Post reported that although some will have completed the process by election day, it is unlikely the manufacturers will have enough data in time to have it approved.

'We want to do everything we can without sacrificing safety or efficacy - we're not going to do that - to make sure that we end up with vaccines that are going to save lives, ' Dr Francis Collins, director of the National Institutes of Health, told reporters. That's prompted widespread concern from scientists and vaccine experts, anxious that the schedule is unscientific.

A huge worldwide study of a COVID-19 vaccine that aims to work with just one dose is getting underway as top US health officials sought Wednesday to assure a skeptical Congress and public that they can trust any shots the government ultimately approves.

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